Member Info for Hulver

Further RNS's with good news are expected.

Remember that Vlad informed that he is presenting on the Company's pipeline of products, which includes CBR and CDX, and today's RNS only covered the update on HG-CT-1.

Fully expecting an update on those two pipeline products very soon (or at least on CBR and the testing outcomes from government linked BSL-3 labs), if not this week then in the half-year report by end September.

Life saving company (evidenced by initial clinical trial results).

Philanthropic funding.

Sounds a compelling combination.

Just checking in today, and I am quite surprised that the focus of discussion on today's RNS has been HG-CT-1. This morning, I actually read the words now capitalised below and immediately thought CBR update and financing (the long overdue CBR test results from the testing with a government connected BSL-3 lab, isn't that how they may got the invite to this conference, and the previously proposed spin-out of CBR into BaitBio, isn't that what venture capital funding is required for next - I actually believe that there is already a buyer in the background for HG-CT-1).

"Hemogenyx will present its clinical progress AND PIPELINE as part of the Summit's curated company showcase. Previous Summit participants have successfully secured significant growth capital, underscoring the Summit's reputation as a catalyst for financing and partnerships.

Participation in the DCNY Summit provides Hemogenyx with a valuable platform to:

· Highlight recent clinical milestones, INCLUDING the ongoing Phase I clinical trial of its lead CAR-T cell therapy for acute myeloid leukemia (AML);

· SHOWCASE THE COMPANY'S BROADER THERAPEUTIC PIPELINE to an audience of influential stakeholders;

· ENGAGE DIRECTLY WITH INVESTORS, collaborators, and decision-makers at the intersection of science, healthcare, and finance."

Thoughts?

Aldebaran

These two items may help. The first is a video report by Nick Short (Hemo's principal investigator) (Dec 2024) and details the inhibitor approach. The second, you will need to register to get a recording of the webinar, but is also Nick Short (in May 2025) outlining the current treatment standards and he also makes reference to the best option for someone with no options left is to register for a clinical trial and that they have one such clinical trial running at MDAnderson (make of that what you will).

https://www.youtube.com/watch?v=JJdpOSxlsTQ

https://healthtree.org/aml/community/events/may2025-acute-myeloid-leukemia-flt3

Thanks HT.

I also note that it was posted here that neither P1 nor P2 had received HSCT post treatment.

Within the trial eligibility detail it states:

"Subjects must have a suitable stem cell transplant donor. Donor may be matched or mismatched and must be found to be suitable according to the institution's standard criteria. That donor shall be "cleared" for donation by institutional standards prior to administration of HG-CT-1. Adult donors can be either related or unrelated, HLA-matched or partially matched. Matched or partially matched umbilical cord blood donors are also eligible."

I don't recall reading that before, maybe I missed it; is anyone confirm if this requirement was always there from P1 onwards, or has it been added?

This update to the clinical trials website suggests that subject to P3 having passed safety, recruitment for a p1 of the first paediatric cohort is open. Remember, about a year ago when Vlad was in London he mentioned that MDAnderson reckoned they could provide all 18 patients for Phase 1 within a shorter period than the FDA would allow the trial to proceed at (I think he may have mentioned one year) so hopefully we will not be waiting long for further update and treatment of the first child (age 12 and over only) and that things will ramp up, which has been stated by Vlad on several occasions.

Per the 6 July 2022 presentation video, which is still available to watch on the videos section of the Company's website and has the clip of the CDX treated mouse skipping around whilst the untreated mice are in varying states of AML paralysis (around 29.30m onwards), with Vlad informing us that "half of these mice are cured forever".

HEMO-CAR-T was already in development and presumably already indicating its superior potential over CDX for treating AML, or perhaps it was just that the pathway for CAR-T was already there and easier and less costly to achieve than pursuing CDX would have been.

In 2021 when Lilly did not take up the option for CDX, were they concerned then about the potential of HEMO-CAR-T?

It looks like Vlad may have made a really smart move in licensing the IP that Lilly had put into CDX (announced Feb 2021) so that now he is in a clean negotiating position with regard to partnering for HG-CT-1 for AML (if there is still a possible competition between the two treatments for AML). CDX however had a much broader application and was considered to have significant value.

The RNS with regard to the Lilly CDX IP licence agreement stated: "Under the Agreement, the Company has agreed to make an up-front payment to Lilly of US$250,000. The Agreement also provides for milestone payments to Lilly of up to US$1 million through to Phase II clinical trials. Lilly is also eligible to receive substantial additional milestone payments based on the achievement of prespecified clinical, regulatory, and commercial milestones upon reaching certain minimum sales, as well as tiered royalties on sales. In addition, the Company will pay Lilly a percentage of any cash payments received in respect of any sub-licence of the licensed IP."

Institutions fighting to get their portion of warrants exercised first??

Only 67,371 out of 197,000 of this batch of one-for-two warrants at £3.50. If I have interpreted that correctly. If not, someone please advise.

An odd number to exercise so maybe that is the remaining headroom utilised by this 11 March "Institution" and if so then maybe it stymies the other "institution" that has warrants from May and June, and which exercised the May warrants earlier in the week at the £1.80 price from exercising its June warrants.

Getting ready for the next trial news update.

Questions need to be asked by the FCA:

The 8th May RNS stated:

"Following allotment of the New Ordinary Shares, Vladislav Sandler has agreed to direct their issue to an institution, who will immediately sell these New Ordinary Shares at the same Issue Price to a purchaser identified by it (the "Purchaser").

Warrants

Concurrent with the purchase of the New Ordinary Shares, the Purchaser will receive warrants from the Company on a one-for-one basis. These warrants will be exercisable for a period of 36 months at an exercise price of 270 pence ("Exercise Price"), subject to adjustment in certain circumstances as set out in the warrant instrument including a reset of the Exercise Price if the Company completes a share issuance (or other transaction granting rights to subscribe for equity securities) during the Exercise Period at a price lower than the Exercise Price."

It seems that there were a number of different short positions opened to take advantage of this over the past two days (just like happened with the placing after FDA clearance). Guessing those that opened the shorts the last few days had connection to the above mentioned institution and knew that this conversion was about to happen. If so I would have thought that's insider trading.

Exactly the same mechanism was repeated for the share issue announced on 3rd June; so we have at least one more of these to look forward to. The board must know the institution they dealt with for these issues. Will they make a report?

Socialist,

"I much prefer to have a patented cash generative product that ensures income for 20-30 years."

I much prefer to have a patented cash generative product that ensures HEMO's future growth (and the future successes of its team of scientists) for the next 20-30 years.

Anyone else think that the CLN raise announced yesterday was specifically towards the commencement of the pediatric cohort and that we should get further news on that soon?

Just prior to that we had the elusive SP Angel Broker Research Note of 21 May 2024 (research-tree.com) released after the FDA clearance was lifted and which was never published on the HEMO website (why, when you are seeking investment?) - it valued HEMO at that time at an Implied Fair Value of £90m which equated to 6.5p per Share (pre-consolidation, equiv £26 now) and that was after a discount of 20% because the trial had not yet started. Adding the discount back would give a fair value at that time of £112.5m or just over 8p (pre-consolidation, equiv £32 now).

That last broker note was prior to the first patient injection, since then the involvement of MD Anderson was announced, an assay was created to help with patient selection; and three adult patients have been treated with no adverse reports and an extension of the trial to pediatrics has been announced.

Could there be a PIPE funding round, or something similar perhaps a spin-out of HG-CT-1 into a subsidiary, still under the majority control of HEMO but with new institutional investors coming directly into the subsidiary. A spin out was supposed to be the direction of travel for CBR, into Bait Biotechnology, per the ResBio conference pitch.

We do not know what has been going on in the background with CDX and CBR. CDX is in IND-enabling studies and Elina was working on those. With regard to CBR, surely they must by now have had the results of the BSL-3 government linked testing of CBR - nothing positive or negative has been announced - does it have any further value. The website shows it as being ready or nearly ready for IND enabling studies to commence in at least three indications. It is strange though that they elected to reduce staff this year.

Here's the link to the reported pipeline on the website which was updated not that long ago (very recently, in Vlad's timescales):

https://hemogenyx.com/pipeline/

It's never been the obvious with HEMO/Vlad before.

Remember we had this RNS on 2 Oct 2024 (how is this to be sorted out if shares cannot be issued at the moment):

Strategic Investment from Prevail Partners, LLC

· Prevail Partners, LLC to invest again in Hemogenyx Pharmaceuticals

· Prevail InfoWorks, Inc. to act as Clinical Research Organization (CRO) for upcoming Phase I pediatric clinical study

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that Prevail Partners, LLC ("Prevail Partners"), an investment fund, has agreed to invest a total of $350,000 (approximately £269,000) in the Company through a subscription for ordinary shares in the Company at a price of US$0.075 per share (approximately 5.6p). This follows a similar investment in the Company by Prevail Partners announced on 18 September 2024. The subscription price represents a premium of approximately 275% to the Company's closing share price on 1 October 2024.

The subscription will take effect in March 2025 ahead of the planned HEMO-CAR-T pediatric study. This will follow the initiation of the adult clinical trial in HEMO-CAR-T at the MD Anderson Cancer Center, Texas, which is expected to commence later this year. The agreement governing the subscription contains customary warranties from the Company and Prevail Partners.

The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed an amendment to the Master Service and Technology Agreement ("MSTA"), (the "Amendment") with Prevail InfoWorks, Inc. ("InfoWorks"), the Philadelphia, PA based Clinical Research Organization ("CRO"), and affiliate of Prevail Partners. Infoworks is already contracted by the Company in relation to the existing planned HEMO-CAR-T clinical trials in adult patients.

The subscription funds received from Prevail Partners will in large part defray the payment made by the Company for the first stage of the work to be undertaken by InfoWorks under the Amendment.

Mary Schaheen, President of Prevail Partners, stated: "Everyone at our fund is confident in the growth and success of Hemogenyx Pharmaceuticals as they develop CAR-T cells to target acute myeloid leukaemia and a subset of acute lymphoblastic leukaemia in children. Furthermore, Hemogenyx Pharmaceuticals has a seasoned management team with the expertise to accelerate the Company to a significant value inflection point through the completion of its planned clinical trial."

Was it a signal?

So we are back at the post consolidation price - the price that Vlad and Peter said was needed for their US institutional investors! Will a fund raise at these levels or higher accompany the announcement of the opening of the pediatric trial recruitment?

IAP, for LTH the new version of the risk slogan is:

"Our investment can go up as well as down!"

- be careful when thinking about selling.

Hemo shouldn't have needed JHFH to organise this. There are paid board members having such responsibility - how do they remain in position?

Briacell Therapeutics (also in the Prevail portfolio) announced a $2m non-dilutive grant yesterday (after their second consolidation of the year though)!

https://feeds.issuerdirect.com/news-release.html?newsid=5240955822312170&symbol=BCTX

Will Hemo get something similar to launch the pediatric trial?

Sounds like you have not had experience of someone suffering from AML to make that comment.

Whilst we know that P1 and P2 are still alive, do we know for certain that P1 has not had a HSCT post treatment with HG-CT-01? Could it be that HG-CT-01 enabled a bridge to HSCT, in a similar way to the existing current approved treatments?

With regard to the increase in dose for P4 adult onwards - does this not imply that they wish to see whether the effects seen in P1 - P2 can be effected in patients quicker and more comprehensively for future patients. I would have thought that the level of dose directly affects the speed and thoroughness of clearance of affected blood cells, but also comes with a potentially increase risk of reaction to the treatment.